BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    QUILL SYNTHETIC ABSORBABLE BARBED SUTURE

    K Number: K051609 · Decision Aug 4, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    84
    Registration Numbers
    84
    Same Product Code
    63
    Applicant Total
    4
    Review Days
    48

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    Basic Information

    Device Name
    QUILL SYNTHETIC ABSORBABLE BARBED SUTURE
    K Number
    K051609
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4840
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Quill Medical, Inc.
    Date Received
    June 17, 2005
    Decision Date
    August 4, 2005
    Product Code
    NEW
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    NEW Suture, Surgical, Absorbable, Polydioxanone

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    Other Clearances by Quill Medical, Inc.

    K Number Device Name
    K052900 QUILL NONABSORBABLE NYLON BARBED SUTURE
    K052373 QUILL NONABSORBABLE POLYPROPYLENE BARBED SUTURE
    K042075 QUILL SYNTHETIC ABSORBABLE BARBED SUTURE